By Lynn L. Bergeson and Carla N. Hutton
The U.S. Department of Agriculture (USDA) announced on April 11, 2023, that its Agricultural Research Service (ARS) recently developed sustainable, machine-washable antimicrobial wipes that can be used at least 30 times for cleaning hard and nonporous surfaces. According to USDA, ARS researchers developed the antimicrobial wipes “by using raw cotton fiber that naturally produced silver nanoparticles inside the fiber in the presence of a silver precursor.” USDA states that the embedded silver nanoparticles then release silver ions that act as antibacterial agents and kill harmful bacteria. USDA notes that in their research, scientists found that the wipes killed 99.9 percent of harmful bacteria S. aureus and P. aeruginosa on surfaces.
USDA states that the advantages to this technology include omitting the conventional pretreatments of raw cotton fibers (such as scouring and bleaching), which consume a large number of chemicals and energy, and not requiring any chemical agents except for a silver precursor. According to USDA, the technology “also transforms cotton fibers themselves into antimicrobial agents rather than serving as a carrier of antimicrobial agents, which is what makes them reusable.” USDA notes that the antimicrobial wipes are made from “natural cotton fibers, rather than conventional petroleum-based synthetic fibers.” The wipes can be reused by being washed in the laundry.
More information on the antimicrobial wipes is available in an article in Molecules entitled “Washable Antimicrobial Wipes Fabricated from a Blend of Nanocomposite Raw Cotton Fiber.”
By Lynn L. Bergeson and Carla N. Hutton
On November 30, 2022, the U.S. Department of Agriculture’s (USDA) Agricultural Research Service (ARS) announced that its scientists have determined that plants could be used to produce nanobodies that quickly block emerging pathogens in human medicine and agriculture. The nanobodies are small antibody proteins naturally produced in specific animals like camels, alpacas, and llamas. ARS researchers evaluated nanobodies to prevent and treat citrus greening disease in citrus trees. The scientists are now using their newly developed and patented SymbiontTM technology to show that nanobodies can be easily produced in a plant system with broad agricultural and public health applications. According to ARS, as a proof-of-concept, researchers showed that nanobodies targeting the SARS-CoV-2 virus could be made in plant cells and remain functional in blocking the binding of the SARS-CoV-2 spike protein to its receptor protein: the process responsible for initiating viral infection in human cells.
AgroSource, Inc. collaborated with ARS to develop the plant-based production system. According to ARS, they are currently taking the necessary steps to see how they can move this advancement into the commercial sector. ARS notes that this research collaboration is in response to the White House’s Executive Order on advancing biotechnology and biomanufacturing innovation for a sustainable, safe, and secure American bioeconomy.
By Lynn L. Bergeson
On March 9, 2020, the U.S. Food and Drug Administration (FDA), in collaboration with the Federal Trade Commission (FTC), will host a public workshop titled “FDA/FTC Workshop on a Competitive Marketplace for Biosimilars.” The focus of the workshop will be on FDA and FTC’s collaborative efforts to support appropriate adoption of biosimilars, deter anticompetitive behaviors in the biologic marketplace, and discourage false or misleading statements about biosimilars. The workshop will take place in Silver Spring, MD, and requires registration. Webcast attendance will also be available. A meeting agenda is expected approximately one week before the meeting. FDA and FTC are also inviting stakeholders to submit electronic or written comments in addition to input at the public workshop. Comments are due on or prior to April 9, 2020.
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.
On January 17, 2020, the European Union (EU) announced a new innovative project called BIOGEARS that will be funded under the European Maritime and Fisheries Fund (EMFF). The project focuses on the development of biobased gear solutions for the creation of an eco-friendly offshore aquaculture sector using a multitrophic approach and new biobased value chains. With the aim to address the gap of biobased ropes for offshore aquaculture, which is currently manufactured with 100 percent non-recyclable plastics, BIOGEARS will create a biobased value chain under the EU Bioeconomy Strategy framework. The European Bioeconomy Strategy aims to accelerate the deployment of a sustainable and circular European bioeconomy to maximize its contribution towards the 2030 Agenda and its Sustainable Development Goals (SDG), as well as the Paris Agreement. With the goal of increasing aquaculture marketable products, BIOGEARS uses an Integrated Multi-Trophic Aquaculture (IMTA) approach by integrating seaweed with mussel production. The BIOGEARS project’s intention is to develop biobased ropes that are tough, durable, and fit-for-purpose while still able to biodegrade in shorter time and managed by local composting facilities.
As part of the project, all project partners will participate in a BLUE LAB to enhance cooperation and enable tracking of innovation of the new biobased materials developed. Project coordinator, Leire Arantzamendi, expressed her hopes of boosting more eco-friendly mussel and seaweed production stating that BIOGEARS “will generate three rope prototypes with a highly reduced carbon footprint along the value chain.” The project will focus on the Atlantic Basin.
By Lynn L. Bergeson
On November 15, 2019, Sarah Yim, M.D., acting director of the Food and Drug Administration (FDA) Office of Therapeutic Biologics and Biosimilars in FDA’s Center for Drug Evaluation and Research, released a statement on FDA’s continued progress facilitating competition in the biologic marketplace with approval of its 25th biosimilar project. In her statement, Dr. Yim highlights FDA’s approval of one of nine new biosimilar products approved in 2019. Bringing the overall total of biosimilar approvals to 25, Dr. Yim states: “I’m pleased to see this progress and am confident that the market for these therapies will continue to grow.” Approved under FDA’s Biosimilar Product Development Program, the 25th biosimilar announced is one of 38 products that have been enrolled in the program. The program’s goal is to discuss development of proposed biosimilar products or interchangeable products, laying the foundation for ongoing competition in the marketplace.
Typically more complex than other drugs and developed through advanced science, biological products, commonly referred to as biologics, are generally made from natural or living sources, such as animal and plant cells, and microorganisms such as bacteria or yeast. Biologics and biosimilar products are highly similar to, and have no clinically meaningful differences from, existing FDA-approved biologic products called reference products. As part of FDA’s efforts to support these products, Dr. Yim also highlighted FDA’s work under the Biosimilars Action Plan. The work under this plan includes efforts to develop and implement new biosimilar-specific review templates and progress toward the development and validation of pharmacodynamic biomarkers tailored to biosimilar development. Part of these efforts involves FDA’s provision of scientific and regulatory clarity for the biosimilar development community, combined with communication and outreach education. Dr. Yim concludes: “The promise of biosimilar and interchangeable biological products in providing increased access to important therapies is great, and the FDA will continue to do all that we can to facilitate competition in this area.”
Bergeson & Campbell, P.C. (B&C®) would like to thank all of the participants that made “TSCA: Three Years Later” such a success. Speakers, including Alexandra Dapolito Dunn, Assistant Administrator, OCSPP, EPA, and Lynn R. Goldman, M.D., M.S., M.P.H., Michael and Lori Milken Dean and Professor of Environmental and Occupational Health at Milken Institute School of Public Health, George Washington University, provided timely insights into EPA’s implementation of the Toxic Substances Control Act (TSCA) now and what should be expected going forward. If you missed the conference on Monday, it is not too late to catch up! A full recording and copies of all presentations are available now on the Environmental Law Institute (ELI) website.
By Lynn L. Bergeson
On May 22, 2019, the U.S. Food and Drug Administration’s (FDA) Department of Health and Human Services (HHS) announced via the Federal Register the availability of a draft guidance for industry titled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.” The draft guidance is a revision of the 2015 guidance titled “Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product.” It provides recommendations on the design and evaluation of comparative analytical studies that intend to demonstrate that a proposed therapeutic protein product is biosimilar to a reference product licensed under the Public Health Service Act (PHS Act). Additionally, the draft guidance makes recommendations to sponsors on the scientific and technical information for the chemistry, manufacturing, and controls (CMC) portion of a marketing application. Comments on the draft guidance are due on or prior to July 22, 2019.
By Lynn L. Bergeson
On May 13, 2019, the U.S. Food and Drug Administration (FDA) issued in final guidance designed to assist sponsors in demonstrating that a proposed biological product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement. This would mean that an abbreviated licensure pathway would be created, where biological products shown to be biosimilar to or interchangeable with an FDA-licensed biological reference product may be submitted without intervention. The guidance focuses on therapeutic protein products, providing an overview of scientific considerations in showing interchangeability of a proposed therapeutic protein product with a reference product. It pertains to a series of guidance documents FDA is developing to implement the Biologics Price Competition and Innovation Act of 2009. This final guidance provides sponsors with more certainty on the development of these proposed interchangeable products. Its scope includes scientific considerations of:
- The data and information needed to support a demonstration of interchangeability;
- The design and analysis of a switching study or studies to support a demonstration of interchangeability;
- The comparator product in a switching study or studies; and
- The development of presentations, container closure systems, and delivery device constituent parts for proposed interchangeable products.
Wondering where we are now and what may happen to the Toxic Substances Control Act (TSCA) reform when Congress is back in session? "TSCA Reform: The Current State of Play," featuring Lynn L. Bergeson and hosted by Compliance & Risks, will bring you up to date on the very latest developments in the Congress and key regulatory developments and initiatives should TSCA reform fail to materialize. If Congress is unable to enact new TSCA measures, many question whether the law will be revised before the Presidential elections in 2016, which means TSCA reform would not occur until 2017 or later. This would put renewed pressure on the U.S. Environmental Protection Agency (EPA) to deploy its current authority in new and even more innovative ways. Free registration is available online.